Document 39VG1kZp8036egjn5r7DMr3y

Ad-Hoc open BCR Meeting -- PFAS Restriction - 28/02/2023 in FPS premises 1. Please fill in this questionnaire if you want to present a topic during the Ad-Hoc PFAS meeting : The document should be send back before 13th March 2023 to: @health.fgov.be and Cc: @health.fgov.be It will help us to frame the agenda and organize the discussion on this large restriction. 2. Your presentation should be shared with the Authorities @health.fgov.be and Cc: @health.fgov.be ) no later than the 20th March 2023 . The presentation should be maximum 5 slides ( the time allowed to each stakeholders will be 10 min max ). 3. The final agenda will follow before the meeting including a Teams link to follow the discussion remotely. Registration is mandatory, not registered stakeholders will not be admitted in the room or online. Questionnaire to send back to the BCR secretariat before the 13 March 2023 - Do you have remarks on the scope (definition of the PFAS ?) o MedTech Europe response: we are still studying the definition. - Please indicate your sector and describe briefly the Restriction impact/influence on your sector . o MedTech Europe response: We represent the manuafacturers of medical technologies. They are used in hospitals, laboratories, and clinics, across Europe in order to analyze, diagnose and treat medical conditions. PFAS are used in a wide range of essential medical devices and in vitro diagnostic medical devices. A ban on PFAS, without derogations, will likely lead to those medical technologies no longer being available to patients and practitioners. - Do you have specific remarks on the restriction text and its exemptions.  Are you concerned by an exemption? o MedTech Europe response: yes, the derogations for medical technologies and components used thereof. If yes, is the timing foreseen reasonable for your sector? o MedTech Europe response: some member companies have raised concerns, however, we need to work with our members and their suppliers to understand what reasonable transitional periods would be. Have you conducted an alternative assessment that indicates that the proposed timing is reasonable or not? o MedTech Europe response: we are currently working on this internally, and it will be submitted as part of the 6month public consultation. Other For any questions, my contact details are: MedTech Europe (website link available here) @medtecheurope.org